Weight RegainWRRFANCT06482411
Risk Factors Affect Weight Loss Outcomes After Treatment.
An observational study of Weight Regain, run by E-DA Hospital at 1 site in Taiwan.
Trial summary
The treatment for weight loss was more diverse due to the higher prevalence of obesity. In addition to weight loss medications, many patients seek bariatric surgery to treat obesity. Although bariatric surgery was the most effective way, the patients still get weight gain due to failure to control their lives. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Weight Regain
- How many people
- 3,602 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Jun 2024to 22 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: More than 30 BMI obese patients consent to join the study.
Who may be able to join
None listed.
Who cannot join
- Once underwent bariatric surgery.
- Once used the GLP-1 receptor agonist.
- Pregnancy or preparation for pregnancy.
- Once and presenting gastric cancer.
- Presenting the other cancer.
- The abnormal endocrine system causes diseases with obesity.
Show all 15Show fewer
- Major organ abnormalities (e.g., kidney failure, liver failure, heart failure, etc.).
- Gastric ulcer, and severe gastroesophageal reflux.
- Severe psychiatric disorders (schizophrenia, severe bipolar disorder, and depression, etc.).
- Bulimia nervosa or anorexia nervosa.
- Drug and alcohol abuse.
- Helicobacter pylori is not for bariatric surgery.
- The following diseases or conditions preclude the use of Contrave: 1)Uncontrolled hypertension, 2) History or current diagnosis of epilepsy, 3) Allergy to this medication, 4) Medications evaluated by a physician to interact with this drug (antidepressants, antipsychotics, liver medications, heart medications).
- The following diseases or conditions preclude the use of GLP-1 medication: 1) History or current diagnosis of medullary thyroid carcinoma, 2)History or current diagnosis of Multiple Endocrine Neoplasia syndrome type 2, 3)Allergy to this medication, 4)Medications evaluated by a physician to interact with this drug (antidepressants, antipsychotics, liver medications, heart medications).
- The following diseases or conditions preclude the use of Xenical medication: 1) History or current diagnosis of cholestasis, 2) Allergy to this medication, 3) Medications evaluated by a physician to interact with this drug (antidepressants, antipsychotics, liver medications, heart medications).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploration of Effect Weight Loss Outcome Related to Factors After Treatment of Weight Loss (WRRFA).
The treatment for weight loss was more diverse due to the higher prevalence of obesity. In addition to weight loss medications, many patients seek bariatric surgery to treat obesity. Although bariatric surgery was the most effective way, the patients still get weight gain due to failure to control their lives. The failure weight loss is caused by complex risk factors, such as dietary habits, quality of life, physical inactivity, comorbidities remission rate, and more related to the failure weight loss factors. To explore weight gain factors, the study uses many questionnaires, including demographic parameter and exercise frequency survey, the WHOQOL-BREF assessment, The Bariatric Quality of Life Questionnaire (BQL), the Three-Factor Eating Questionnaire (TFEQ-R18), the Yale Food Addiction Scale version 2.0 (YFAS 2.0), and Depression Anxiety Stress Scales-21 (DASS-21). The investigators assess different factors like quality of life, food addiction, preferences, psychological status, and regular examination parameters to identify reasons for unsuccessful weight loss. The study aims to establish the model for the prediction of risk factors after treatment of weight loss so that the tools will help to manage the best weight control for the future.
Read the detailed description
Obesity is a disease worldwide. Hence, many patients seek many different treatments for obesity. The methods for obesity include medical and surgical treatment. The medicine treatment indication for diabetes previously increased indication to weight loss for obese patients now. Recently, the four approved weight loss medicines by the Taiwan Food and Drug Administration (TFDA) include Orlistat, Liraglutide, Contrave, and Semaglutide. In addition to medications for weight loss, indications for more than 30 body mass index (BMI) and more than 27 BMI with uncontrol obesity-related comorbidities.
Another weight loss treatment was bariatric surgery. The surgical treatment focuses on morbidity obese patients. Decrease food intake and absorb calories by changing the structure of the stomach and intestine to weight loss and improve comorbidities. Moreover, three functions for bariatric surgery by different mechanisms to weight loss outcome, include (1) restriction, (2) malabsorption, (3) mixed function, and which indication for more than 37.5 BMI and more than 32.5 BMI with two or more uncontrol obesity-related comorbidities.
Since obesity is not a condition that can be cured by surgical removal of lesions forever, patients often experience weight loss failure after receiving both medical and surgical treatments. Particularly, the probability of weight loss failure after medical treatment is higher than that after surgical treatment. Complexed risk factors caused failure weight loss from behavioral dietary, quality of life, remission rate of comorbidities, genetic inheritance, physical Inactivity, and psychological status. Moreover, failure weight loss has two definitions (1) weight regain (WR) and (2) insufficient weight loss (IWL). The investigators searched many studies to organize failure weight loss definitions referenced by Surgery for Obesity and Related Disease (SORD) in the American Society for Metabolic and Bariatric Surgery (ASMBS). IWL is defined as less than 50 percent excess weight loss (%EWL) or less than 35 BMI after 18 months. WR is defined as (1) more than the nadir weight of 10 kg (2) more than the nadir weight of 25% EWL (3) more than the nadir weight of 5 BMI (4) successfully reduced to a BMI below 35, but after 1-year post-treatment, it exceeded BMI 35 (5) at any point within 1-year post-treatment, the weight is higher than the lowest weight achieved. (6) the weight regained is more than 15% of the lowest weight achieved. In contrast to weight gain after medicine which is defined by population proportion 5%, 10%, 15%, 20% statistical analysis.
The study was an observational cohort study. The investigators will use the six types of questionnaires (1) Demographic parameters and exercise frequency (2) WHOQOL-BREF scale (3) Bariatric Quality of Life Questionnaire (BQL) (4) Three-Factor Eating Questionnaire (TFEQ-R18) (5) Yale Food Addiction Scale (YFAS)2.0 (6) Depression Anxiety Stress Scales-21 (DASS-21). Approximately 5,000 adults who underwent bariatric surgery between January 2017 and December 2024 have been identified for inclusion. The investigators hypothesize that these risk factors are significantly interrelated and are associated with suboptimal weight loss or weight regain following surgery. The primary aim is to analyze the risk of weight regain across different bariatric treatments and identify factors that can support long-term, quality weight management.
- Conditions
- Weight Regain
- Keywords
- Obesity, Weight regain, Bariatric surgery, Anti-obesity medications, Lifestyle intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-Surgical group | Participants were treated with anti-obesity medications plus lifestyle intervention therapy Participants were treated with TFDA-approved anti-obesity medications (e.g. Saxenda, Contrave, etc.). | |
| LSG | Bariatric surgery group(Restriction procedure): Laparoscopic Sleeve Gastrectomy | |
| OAGB | Bariatric surgery group(Restriction procedure): One anastomosis gastric bypass | |
| SASI | Bariatric surgery group(Restriction procedure): Single Anastomosis Sleeve Ileal Bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of failure weight loss
Compare the proportion of failure weight loss after bariatric surgery and medication plus life intervention at 1, 1.5, and 2 years.
Measured: Month 6, Year 1, Year 1.5, Year 2
Secondary outcomes (12)
The percentage of total weight loss changes
Change from Baseline in percentage of total weight loss
Measured: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Weight change
Change from Baseline in weight change
Measured: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
BMI change
Change from BMI in weight change
Measured: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Exercise change
Change from baseline in exercise frequency
Measured: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Physiological parameter change
Change from baseline in physiological parameter.
- Concentration of blood sugar test, such as fasting blood glucose (mg/dL), HbA1c (%), C-peptide (ng/dL), Insulin (μIU/mL).
- Concentration of blood lipid test, such as total choleserol (mg/dL), TG (mg/dL), HDL-C (mg/dL), LDL-C (mg/dL). Concentration of liver and renal function test, such as ALT (U/L), AST (U/L), eGFR (mL/min/1.73m2), creatnine (mg/dL).
- Concentration of urine and anemia test, such as uric acid (mg/dL), hemoglobin (g/dL), HCT (%), Fe (ug/dL).
- Concentration of micro-nutrient test, such as IPTH (pg/mL), Ca (mEq/L), Zinc (ug/dL).
Above all, the biochemistry with patients at the hospital.
Measured: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
The comorbidity remission rate.
Change from baseline in proportion of comorbidity remission
Measured: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Complication events.
Change from baseline in proportion of Complication events
Measured: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Health quality of life change
Change from Baseline in World Health Organization Quality-of-Life Scale (WHOQOL-BREF).The questionnaire has 28-items and belong to four domains (physical, psychological, social, quality of life). Use a Likert-type five-point scale, and higher the score, the better the quality of life. The 4 domain scores are each converted into a scale from 0 to 100.
Measured: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Quality of life after weight loss treatment change
Change from Baseline in Bariatric Quality of Life Questionnaire (BQL). The questionnaire consists of two main parts and has 15-items. Obesity comorbidities and complications after treatment.The factors related to quality of life. The total score of both parts ranges from 0 to 78, with a higher score indicating better quality of life.
Measured: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Eating behavior
Change from Baseline in Three-Factor Eating Questionnaire (TFEQ-R18). The questionnaire has 18-items and consist three domains (1) Cognitive Restraint (CR), (2) Uncontrolled Eating (UE), and (3) Emotional Eating (EE). Use a Likert-type four-point scale, and the total score ranges from 18 to 72, with the higher score, prefer the domain.
Measured: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Food addiction
Change from Baseline in Yale Food Addiction Scale (YFAS)2.0. The questionnaire has 25-items. Absence of food addiction: 0-1 point. Mild food addiction: 2-3 points. Moderate food addiction: 4-5 points. Severe food addiction: ≥ 6 points. Higher score indicating poorer control to food eat.
Measured: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Psychiatric status
Change from Baseline in Depression Anxiety Stress Scales-21 (DASS-21). The questionnaire has 21-items and consist three domains. Depression domain has score rang of 0-14 points. Higher score has severe depression. Anxiety domain has score rang of 0-10 points. Higher score has severe Anxiety. Stress domain has score rang of 0-17 points. Higher score has severe Stress.
Measured: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start27 Jun 2024
- Primary completion22 Oct 2025
- Study completion22 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight RegainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 3,602 participants (actual)
Sponsor and investigators
- Lead sponsor
- E-DA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen,Chung-Yen, E-DA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482411
- Sponsor's protocol ID
- EMRP19113N
- Acronym
- WRRFA
- Status last verified
- Jan 2026
- First submitted
- 17 Jun 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Effect Weight Loss Outcome Related to Factors After Treatment of Weight Loss (WRRFA).
- ClinicalTrials.gov ID
- NCT06482411
- Acronym / sponsor ID
- WRRFA / EMRP19113N
- Conditions
- Weight Regain
- Keywords
- Obesity, Weight regain, Bariatric surgery, Anti-obesity medications, Lifestyle intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,602 participants (actual)
- Lead sponsor
- E-DA HospitalUniversity, hospital or other
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- 22 Oct 2025 (actual)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The treatment for weight loss was more diverse due to the higher prevalence of obesity. In addition to weight loss medications, many patients seek bariatric surgery to treat obesity. Although bariatric surgery was the most effective way, the patients still get weight gain due to failure to control their lives. The failure weight loss is caused by complex risk factors, such as dietary habits, quality of life, physical inactivity, comorbidities remission rate, and more related to the failure weight loss factors. To explore weight gain factors, the study uses many questionnaires, including demographic parameter and exercise frequency survey, the WHOQOL-BREF assessment, The Bariatric Quality of Life Questionnaire (BQL), the Three-Factor Eating Questionnaire (TFEQ-R18), the Yale Food Addiction Scale version 2.0 (YFAS 2.0), and Depression Anxiety Stress Scales-21 (DASS-21). The investigators assess different factors like quality of life, food addiction, preferences, psychological status, and regular examination parameters to identify reasons for unsuccessful weight loss. The study aims to establish the model for the prediction of risk factors after treatment of weight loss so that the tools will help to manage the best weight control for the future.
Detailed description
Obesity is a disease worldwide. Hence, many patients seek many different treatments for obesity. The methods for obesity include medical and surgical treatment. The medicine treatment indication for diabetes previously increased indication to weight loss for obese patients now. Recently, the four approved weight loss medicines by the Taiwan Food and Drug Administration (TFDA) include Orlistat, Liraglutide, Contrave, and Semaglutide. In addition to medications for weight loss, indications for more than 30 body mass index (BMI) and more than 27 BMI with uncontrol obesity-related comorbidities.
Another weight loss treatment was bariatric surgery. The surgical treatment focuses on morbidity obese patients. Decrease food intake and absorb calories by changing the structure of the stomach and intestine to weight loss and improve comorbidities. Moreover, three functions for bariatric surgery by different mechanisms to weight loss outcome, include (1) restriction, (2) malabsorption, (3) mixed function, and which indication for more than 37.5 BMI and more than 32.5 BMI with two or more uncontrol obesity-related comorbidities.
Since obesity is not a condition that can be cured by surgical removal of lesions forever, patients often experience weight loss failure after receiving both medical and surgical treatments. Particularly, the probability of weight loss failure after medical treatment is higher than that after surgical treatment. Complexed risk factors caused failure weight loss from behavioral dietary, quality of life, remission rate of comorbidities, genetic inheritance, physical Inactivity, and psychological status. Moreover, failure weight loss has two definitions (1) weight regain (WR) and (2) insufficient weight loss (IWL). The investigators searched many studies to organize failure weight loss definitions referenced by Surgery for Obesity and Related Disease (SORD) in the American Society for Metabolic and Bariatric Surgery (ASMBS). IWL is defined as less than 50 percent excess weight loss (%EWL) or less than 35 BMI after 18 months. WR is defined as (1) more than the nadir weight of 10 kg (2) more than the nadir weight of 25% EWL (3) more than the nadir weight of 5 BMI (4) successfully reduced to a BMI below 35, but after 1-year post-treatment, it exceeded BMI 35 (5) at any point within 1-year post-treatment, the weight is higher than the lowest weight achieved. (6) the weight regained is more than 15% of the lowest weight achieved. In contrast to weight gain after medicine which is defined by population proportion 5%, 10%, 15%, 20% statistical analysis.
The study was an observational cohort study. The investigators will use the six types of questionnaires (1) Demographic parameters and exercise frequency (2) WHOQOL-BREF scale (3) Bariatric Quality of Life Questionnaire (BQL) (4) Three-Factor Eating Questionnaire (TFEQ-R18) (5) Yale Food Addiction Scale (YFAS)2.0 (6) Depression Anxiety Stress Scales-21 (DASS-21). Approximately 5,000 adults who underwent bariatric surgery between January 2017 and December 2024 have been identified for inclusion. The investigators hypothesize that these risk factors are significantly interrelated and are associated with suboptimal weight loss or weight regain following surgery. The primary aim is to analyze the risk of weight regain across different bariatric treatments and identify factors that can support long-term, quality weight management.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-Surgical group | – | –Participants were treated with anti-obesity medications plus lifestyle intervention therapy Participants were treated with TFDA-approved anti-obesity medications (e.g. Saxenda, Contrave, etc.). |
| LSG | – | –Bariatric surgery group(Restriction procedure): Laparoscopic Sleeve Gastrectomy |
| OAGB | – | –Bariatric surgery group(Restriction procedure): One anastomosis gastric bypass |
| SASI | – | –Bariatric surgery group(Restriction procedure): Single Anastomosis Sleeve Ileal Bypass |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- More than 30 BMI obese patients consent to join the study.
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- Once underwent bariatric surgery.
- Once used the GLP-1 receptor agonist.
- Pregnancy or preparation for pregnancy.
- Once and presenting gastric cancer.
- Presenting the other cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of failure weight loss
Time frame: Month 6, Year 1, Year 1.5, Year 2
Compare the proportion of failure weight loss after bariatric surgery and medication plus life intervention at 1, 1.5, and 2 years.
12 secondary outcomes
The percentage of total weight loss changes
Time frame: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Weight change
Time frame: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
BMI change
Time frame: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Exercise change
Time frame: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Physiological parameter change
Time frame: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
The comorbidity remission rate.
Time frame: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Complication events.
Time frame: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Health quality of life change
Time frame: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Quality of life after weight loss treatment change
Time frame: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Eating behavior
Time frame: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Food addiction
Time frame: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Psychiatric status
Time frame: Follow-up 8 times (Baseline, Month 1, Month 3, Month 6, Month 9, Year 1, Year 1.5, Year 2) visit for all secondary outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Regain, run by E-DA Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of failure weight loss (time frame: Month 6, Year 1, Year 1.5, Year 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.